Pharmaceutical access in medical security systems and health policy mobilization: cross-national evidence on TRIPS compulsory licensing from 2001 to 2024.

Background: Pharmaceutical access is essential for medical security systems to convert health protection commitments into actual treatment coverage. TRIPS compulsory licensing gives WTO members legal space to limit patent exclusivity under specific conditions, but legal authorization does not automatically become health policy mobilization. Existing research has not sufficiently tested the public health pressure and governance resource conditions under which compulsory licensing is mobilized in a WTO-corrected country-year risk set. Methods: Drawing on the Medicines Law & Policy TRIPS Flexibilities Database, UNAIDS, the Global Fund, the World Bank, and WHO, this study constructs a country-year panel of 103 WTO members from 2001 to 2024, with 2,276 observations. Two-way fixed effects linear probability models are used as the main analysis of the institutional mobilization conditions of compulsory licensing-related events. GEE, first-event, and Poisson models are used as robustness checks, while HIV/AIDS-related compulsory licensing models and ART coverage outcome models are used as supplementary boundary analyses. ART coverage is treated only as an indicator of HIV/AIDS treatment access, not as a general measure of access to medicines. Results: Lower ART coverage is relatively consistently and negatively associated with compulsory licensing events, and supplementary analyses of HIV/AIDS-related compulsory licensing support the same direction. Observed Global Fund HIV assistance is positively associated with compulsory licensing under the all-event measure and in several robustness models, suggesting that governance-resource connections may be associated with the feasibility of converting legal flexibilities into policy action. AIDS deaths, TB incidence, GDP per capita, health expenditure, out-of-pocket expenditure, and manufactured exports do not show stable main effects across models. Supplementary outcome-boundary models do not support the claim that HIV/AIDS-related compulsory licensing significantly increases ART coverage. Discussion: TRIPS compulsory licensing is better understood as a health policy instrument addressing pharmaceutical access risks within medical security systems. In the current observational panel, its mobilization is associated with HIV/AIDS treatment access pressure and observed governance-resource connections, rather than operating as a medicine access improvement mechanism that current cross-national data can directly establish.